Observed Rates of Major Bleeding Over Time According to Treatment Group

LAA Closure(n = 732)

Long-Term Warfarin(n = 382)

Rate Ratio (95% CI)

p Value

Bleeding Rate (n events/N at risk)

Event Rate/100 pt-yrs (n events/pt-years)

Bleeding Rate (n events/N at risk)

Event Rate/100 pt-yrs (n events/pt-years)

Overall

10.8 (79/732)

3.5 (79/2,268)

11.3 (43/382)

3.6 (43/1,187)

0.96 (0.66–1.40)

0.84

Post-procedural

5.9 (40/682)

1.8 (40/2,255)

11.3 (43/381)

3.6 (43/1,180)

0.49 (0.32–0.75)

0.001

Destination therapy

3.2 (19/601)

1.0 (19/1,958)

9.7 (35/360)

3.5 (35/1,004)

0.28 (0.16–0.49)

<0.001

Values are % (n/N). The overall period was defined as after randomization to the end of follow-up; post-procedural period as >7 days after randomization to the end of follow-up, thereby isolating nonprocedural related bleeding events; and destination therapy period as beyond 180 days post-randomization, when patients assigned to LAA closure were eligible to receive aspirin alone. Patients were randomized in a 2:1 fashion to either LAA closure or long-term warfarin.